NCT06276543 Bactiseal Catheter Safety Registry Study
| NCT ID | NCT06276543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Integra LifeSciences Corporation |
| Condition | Hydrocephalus |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-09-29 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-09-29 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Research Purpose: This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter. Research Design: This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022. The following information will be collected from subjects' medical records or hospitals' databases (if any): 1. General condition of the subjects (including previous shunting and external drainage operation) 2. Intraoperative condition and catheter implantation 3. Information on the shunt catheters 4. Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2) 5. Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)
Eligibility Criteria
Inclusion Criteria: 1. The informed consent is exempted by the Ethics Committee of a research center. Or a subject or his/her legal representative signed the informed consent form (ICF) prior to the enrollment. 2. A subject had an indication suitable to use Bactiseal Catheter. 3. A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment. Exclusion Criteria: 1. A subject didn't have an indication suitable to use the catheter. 2. A subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin. 3. According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt is implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection. 4. A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter. 5. A subject had a contraindication of the shunt operation. 6. A subject had uncorrected coagulopathy or any bleeding disorder.
Contact & Investigator
Nan Bao, MD
PRINCIPAL INVESTIGATOR
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
Frequently Asked Questions
Who can join the NCT06276543 clinical trial?
This trial is open to participants of all sexes, studying Hydrocephalus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06276543 currently recruiting?
Yes, NCT06276543 is actively recruiting participants. Contact the research team at hua.tang@integralife.com for enrollment information.
Where is the NCT06276543 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Guangzhou, China, Harbin, China and 4 additional locations.
Who is sponsoring the NCT06276543 clinical trial?
NCT06276543 is sponsored by Integra LifeSciences Corporation. The principal investigator is Nan Bao, MD at Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine. The trial plans to enroll 200 participants.